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CTRI Number  CTRI/2018/02/011957 [Registered on: 19/02/2018] Trial Registered Prospectively
Last Modified On: 16/02/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Dentistry 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   comparison between tissue adhesive and suturing technique for wound closure after impacted lower wisdom tooth removal 
Scientific Title of Study   comparison of the efficacy between tissue adhesive and standard suturing for flap closure after impacted mandibular third molar odontectomy 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sajeesh Raj A 
Designation  post graduate student 
Affiliation  coorg institute of dental sciences 
Address  coorg institute of dental sciences kanjithanda kushalappa campus maggula village virajpet p o kodagu karnataka

Kodagu
KARNATAKA
571218
India 
Phone  9496053291  
Fax    
Email  srajkadavoor@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Adarsh S Indra 
Designation  professor 
Affiliation  coorg institute of dental sciences 
Address  coorg institute of dental sciences kanjithanda kushalappa campus maggula village virajpet p o kodagu karnataka

Kodagu
KARNATAKA
571218
India 
Phone  9895258147  
Fax    
Email  adarshsindra@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Adarsh S Indra 
Designation  professor 
Affiliation  coorg institute of dental sciences 
Address  coorg institute of dental sciences kanjithanda kushalappa campus maggula village virajpet p o kodagu karnataka

Kodagu
KARNATAKA
571218
India 
Phone  9895258147  
Fax    
Email  adarshsindra@gmail.com  
 
Source of Monetary or Material Support  
coorg institute of dental sciences kanjithanda kushalappa campus maggula village virajpet p o kodagu district karnataka 
 
Primary Sponsor  
Name  Dr sajeesh Raj A 
Address  coorg institute of dental sciences kanjithanda kushalappa campus maggula village virajpet kodagu karnataka 
Type of Sponsor  Other [private dental college] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sajeesh Raj A  coorg institute of dental sciences maggula village virajpet p o kodagu district karnataka  room no 2 department of oral and maxillofacial surgery division of minor oral surgery
Kodagu
KARNATAKA 		 9496053291

srajkadavoor@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional review board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  impacted mandibular third molar,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  3-0 black braided silk suture  following the disimpaction the flap will be closed with 3-0 black braided silk suture in group 2. all patients will be evaluated on 1st 3rd 7th 15th day postoperatively 
Intervention  N-butyl 2 cyanoacrylate tissue adhesive  following the disimpaction , the flap will be closed with N butyl 2 cyanoacrylate in group 1 and patient will be evaluated on 1st 3rd 7th 15th day operatively 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Impacted mandibular third molar with complete flap coverage no history of pericoronitis and previous infection patients with adequate mouth opening 
 
ExclusionCriteria 
Details  chronic smokers allergic to drugs or anesthetic agents poor oral hygiene patients lost to follow up patients under oral contraceptives patients under radiotherapy or chemotherapy diabetic patients patients on immunosuppressants 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
comparison between the efficacy between the tissue adhesive and standard suturing  2 years 
 
Secondary Outcome  
Outcome  TimePoints 
comparison of postoperative bleeding, pain, wound dehiscence and wound healing  2 years 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   24/02/2018 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   trial not yet started 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   Impaction of mandibular third molar is one of the common problem in dentistry.. It’s prevalence is about 16.7-68.6%. In my study i would evaluate the efficacy of cyanoacrylate glue which can be used for wound closure. Aim of the study is to compare the efficacy between tissue adhesive and standard suturing following the impacted mandibular third molar odontectomy for flap closure. In this prospective blinded study I will include 100 healthy consented individuals of age group 18-40 years who are indicated to undergo surgical removal of mandibular third molar under local anaesthesia .   The patients are divided into 2 groups , each consisting of 50 patients . In group 1 , individuals are given conventional suturing after mandibular third molar removal. In group 2, individuals who are given cyanoacrylate glue after mandibular third molar removal. All patients will be undergoing routine hemogram before the procedure . They will be prepared in standard manner and taken up under proper aseptic condition.. Following the procedure by adequate curettage , debridement and thorough irrigation and the flap will be closed with cyanoacrylate glue in group 1 where as vicryl 3-0 sutures used in group 2. They will be given a long acting anesthetic post operatively. Patients will be prescribed similar analgesics for 3 days and antibiotic for 5 days postoperatively.  Postoperative bleeding , pain, wound dehiscence and wound healing are evaluated on the 1st 3rd 7th and 15th day postoperatively.  
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